QA Manager and Responsible Person (RP)

Smart4Sciences; Birmingham; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading logistics partner in Birmingham is seeking a Quality Manager & Responsible Person to oversee quality operations. The role involves compliance with GDP, MHRA, and ISO standards, managing a quality team, and liaising with clients. Extensive experience in quality assurance within the pharmaceutical or medical device sectors is required, along with leadership skills. This position offers a full benefits package and opportunities for growth within a respected organization.

Benefits

Full benefits package including healthcare and pension

Opportunities for growth within a respected organization

Collaborative and values-driven work culture

Qualifications

• Extensive experience in a logistics/distribution setting.
• Solid understanding of Good Distribution Practice and Falsified Medicines Directive.
• Working knowledge of environmental monitoring and ISO standards.

Responsibilities

• Lead and manage on-site Quality department operations.
• Act as the Responsible Person for MHRA licences.
• Ensure implementation of Quality Management System.

Skills

Extensive experience in pharmaceutical or medical device quality assurance

Strong leadership and mentoring skills

Excellent communication and stakeholder management capabilities

Proficient in Microsoft Office and quality systems

Education

Eligible to act as Responsible Person under MHRA WDA(H) and WQP guidelines

Job description

Join a leading logistics partner to the healthcare and pharmaceutical industry, as a Quality Manager & Responsible Person (RP). This is a crucial leadership role, responsible for site-level Quality operations, ensuring full compliance with GDP, MHRA, ISO, and internal quality systems.

Key Responsibilities

• Lead and manage the on-site Quality department, overseeing personnel, operations, and performance.
• Act as the named Responsible Person for MHRA licences, ensuring adherence to GDP (2013/C 343/01).
• Ensure robust implementation of the Quality Management System including deviations, CAPAs, change control, and self-inspections.
• Maintain compliance with GxP, ISO 9001, ISO 13485, and regulatory standards.
• Conduct internal and external training on key QA topics and regulatory requirements.
• Oversee supplier management, quality risk assessments, validation processes, and complaint handling.
• Lead audit readiness and host MHRA, ISO, and client audits, ensuring timely resolution of any findings.
• Act as a key quality liaison for clients, attending meetings and maintaining strong working relationships.
• Prepare, review, and approve Technical and Quality Agreements.
• Ensure traceability of recalls and release of returned and quarantined stock in accordance with MHRA guidelines.

About You

• Extensive experience in pharmaceutical or medical device quality assurance, preferably in a logistics/distribution setting.
• Eligible to act as Responsible Person (RP) under MHRA WDA(H) and WQP guidelines.
• Solid understanding of Good Distribution Practice (GDP) and the Falsified Medicines Directive.
• Working knowledge of environmental monitoring, computer systems validation, and ISO standards.
• Strong leadership, mentoring, and coaching skills - able to manage and motivate cross-functional teams.
• Excellent communication and stakeholder management capabilities.
• Proficient in Microsoft Office and quality systems; Lead Auditor certification is desirable.
• Willing to travel nationally and occasionally within Europe.

What's on Offer

• Full benefits package including healthcare and pension.
• Opportunities to grow within a respected, international organisation.
• Collaborative and values-driven work culture.

Apply now to join a high-impact team where your expertise ensures the safe, compliant delivery of life-saving products or contact Gareth Gooley at Smart4 Sciences on